Press Release

Kyowa Hakko Kirin Joins Certara’s Simcyp Consortium

Certara®, the global leader in model-informed drug development and
regulatory science, today announced that Kyowa Hakko Kirin Co., Ltd. has
joined the Simcyp Consortium and licensed the Simcyp® Population-based
Simulator. Kyowa Hakko Kirin is the 36th leading biopharmaceutical
company and the 11th Japanese pharmaceutical company to join the
Consortium. Member companies meet in a pre-competitive environment and
work together to progress the evolution of modeling and simulation (M&S)
and the Simcyp Simulator.

“We are thrilled to have Kyowa Hakko Kirin as a member of the Simcyp
Consortium,” said Stephen Toon, BPharm, PhD, President and Managing
Director of Certara’s Simcyp division. “Membership provides numerous
benefits, including the opportunity to share knowledge and collaborate
in the development of best practices and cutting-edge science for
studying drug activity in virtual patients. In addition to creating
annual updates to the Simcyp Simulator, Simcyp has also produced models
for pediatric, pregnant, obese, hepatic- and renally-impaired
populations. These advances have enabled member companies to evaluate
new therapies in patient groups and clinical scenarios that might have
historically been considered ‘untestable.’”

Underscoring that fact that M&S has progressed from a scientific nicety
to a regulatory necessity, leading academic institutions and key
regulatory bodies from around the world, including the US Food and Drug
Administration (FDA), European Medicines Agency, and Japanese
Pharmaceuticals and Medical Devices Agency (PMDA) are affiliates of the
Simcyp Consortium.

In the US, the Simcyp Simulator has informed more than 100 label claims
for new drug and biologic approvals from FDA. Those label additions
include potential drug-drug interactions (DDIs), formulation
recommendations, dosing regimens, and data about new populations.

M&S is also increasingly being included in Japanese new drug
applications (NDAs). PMDA announced in June that between 2014 and 2016,
physiologically-based pharmacokinetic (PBPK) M&S reports were included
in 17 NDAs.1 In those instances, M&S was used primarily to
evaluate DDIs, predict drug exposure in pediatric patients, and
determine the impact of ethnic differences and disease states on drug PK.1

The Simcyp Consortium was formed in 2001 to serve as a collaborative
research center for PBPK and mechanistic modeling. Simcyp is now
considered a global authority on PBPK and mechanistic M&S sciences, and
the Simcyp Simulator has become the most sophisticated platform for
predicting PK outcomes in virtual patient populations.

Simcyp Simulator data are used to inform a wide range of important
management decisions, including formulation and clinical trial design,
and the need for specific clinical trials, in addition to determining
dosing in special populations and predicting the likelihood of DDIs.
They can also identify preclinical data requirements, helping to refine
early drug development processes and procedures.

Certara is a leading decision support technology and consulting
organization committed to optimizing drug development and improving
health outcomes. Certara’s solutions, which span drug discovery through
patient care, use the most scientifically-advanced modeling and
simulation technologies and regulatory strategies to increase the
probability of regulatory and commercial success. Its clients include
hundreds of global biopharmaceutical companies, leading academic
institutions, and key regulatory agencies. For more information, visit www.certara.com.

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